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Solid TumorPhase 1NCT02076230

A Phase 1 TH-302 Mass Balance Trial

A Phase 1 study testing [14C] TH-302 (Label 1), [14C] TH-302 (Label 2) and Unlabeled TH-302 in people with Solid Tumor, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, Phase 1, two-center trial to evaluate the mass balance and metabolite profile of carbon 14 [14C]-labeled TH-302 (Label 1 and Label 2) followed by subsequent treatment with unlabeled TH-302 in cancer subjects with locally advanced or metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 to 70 years, men only
Conditions the study is for
Solid Tumor
What is being tested?
[14C] TH-302 (Label 1), [14C] TH-302 (Label 2) and Unlabeled TH-302
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteGermany
Study dates
Feb 2014to Mar 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male subject with pathologically or cytologically confirmed solid tumor which is locally advanced or metastatic, and either refractory to the standard therapy or for which no effective standard therapy is available
  • Subject has measurable and evaluable disease as RECIST version 1.1
  • Age greater than or equal to (>=) 18 years and less than or equal to (=<) 70 years
  • Body mass index (BMI) >= 19 and =< 33 kilogram per square meter (kg/m^2), body weight greater than (>) 50 kilogram (kg)
  • Eastern cooperative oncology group (ECOG) performance status of 0 to 1
  • Life expectancy of at least 3 months
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  • At least 4 weeks from previous cytotoxic chemotherapy or radiation therapy and at least 5 half-lives or 6 weeks, whichever is longer, after targeted or biologic therapy
  • Acceptable renal function, liver function and hematologic status as defined in the protocol
  • Other protocol-defined inclusion criteria could apply

Who cannot join

  • New York Heart Association (NYHA) Class 3 or 4 congestive heart disease, myocardial infarction within 6 months, unstable arrhythmia, symptomatic ischemic heart disease or symptomatic peripheral arterial vascular disease
  • Severe chronic obstructive or other pulmonary disease with hypoxemia as defined in the protocol
  • Major surgery, other than diagnostic surgery, =< 28 days prior to Day 1. Subject must have completely recovered from surgery
  • Primary brain tumors or clinical evidence of active brain metastasis as defined in the protocol
  • Treatment with strong inhibitors and/or inducers of drug metabolic enzymes or drug transporter as defined in the protocol
  • Participation in a drug trial within 30 days prior to start of trial medication. Participation in a trial involving administration of 14C-labeled compound(s) within last 6 months prior to start of study drug
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  • Inability to understand the protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial
  • Legal incapacity or limited legal capacity
  • Other protocol-defined exclusion criteria could apply

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Please contact the Merck KGaA Communication Center located in

    Darmstadt

Other trials in Germany

About this study

Official title: A Phase I, Open-Label, Two-Center Trial to Investigate the Mass Balance and Metabolite Profile of TH-302 in Cancer Patients With Locally Advanced or Metastatic Solid Tumors

This is an open-label, Phase 1, two-center trial to evaluate the mass balance and metabolite profile of carbon 14 [14C]-labeled TH-302 (Label 1 and Label 2) followed by subsequent treatment with unlabeled TH-302 in cancer subjects with locally advanced or metastatic solid tumors.

Conditions
Solid Tumor
Being tested
[14C] TH-302 (Label 1), [14C] TH-302 (Label 2), Unlabeled TH-302
Keywords
14C-TH-302, Advanced or Metastatic Solid Tumors, Evofosfamide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C] TH-302 (Label 1)Drug

    [14C]-labeled TH-302 (Label 1) will be administered as intravenous infusion over 30 minutes on Day 1 of Part A.

  • [14C] TH-302 (Label 2)Drug

    [14C]-labeled TH-302 (Label 2) will be administered as intravenous infusion over 30 minutes on Day 1 of Part A.

  • Unlabeled TH-302Drug

    Unlabeled TH-302 will be administered along with labeled TH-302 at the dose of 340 milligram per square meter (mg/m^2) as intravenous infusion over 30 minutes on Day 1 of Part A, followed by recommended Phase 2 dose (RP2D) of 480 mg/m^2 as monotherapy infusion over 30 minutes on Days 8 and 15 of Part A; and on Days 1, 8 and 15 of Part B, until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow up, or death.

Study groups in NCT02076230
Study groupRoleWhat they receive
[14C] TH-302 (Label 1)ExperimentalNot described
Receives: Drug: [14C] TH-302 (Label 1); Drug: Unlabeled TH-302
[14C] TH-302 (Label 2)ExperimentalNot described
Receives: Drug: [14C] TH-302 (Label 2); Drug: Unlabeled TH-302

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics profile in plasma: Cmax, Tmax, AUC (0-t), lambda_z, t1/2, AUC (0-infinity), CL, Vss, Vz, MRT for TH-302 and its active metabolite Br-IPM

    Measured: Days 1 and 8 of Cycle 1

  2. Pharmacokinetics profile in excreta: Cumulative Ae (0-t), Ae (0-infinity), percent radioactive dose excreted in urine and feces, AeUF, CLR, CLNR for TH-302 and its active metabolite Br-IPM

    Measured: Day 1 of Cycle 1

Secondary outcomes (5)

  1. Number of subjects with Treatment-emergent adverse events (TEAEs)

    Measured: Baseline up to Day 30 after the last dose of study treatment

  2. Blood to plasma ratio of total 14C-radioactivity

    Measured: Days 1 and 8 of Cycle 1

  3. Total and free plasma concentrations of TH-302 in plasma

    Measured: Day 1 of Cycle 1

  4. Number of subjects with tumor response according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)

    Tumor response was defined as the occurrence of complete response (CR) or partial response (PR) based on the investigator's assessment according to RECIST v 1.1.

    Measured: Up to 1 year

  5. Unbound fraction (fu) of TH-302 in plasma

    Measured: Day 1 of Cycle 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionSep 2014
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02076230
Sponsor's protocol ID
EMR200592-007
Other IDs
2013-003950-25
Status last verified
Jun 2016
First submitted
20 Feb 2014
Last updated
10 Jun 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C] TH-302 (Label 1), [14C] TH-302 (Label 2) and Unlabeled TH-302 in people with Solid Tumor, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics profile in plasma: Cmax, Tmax, AUC (0-t), lambda_z, t1/2, AUC (0-infinity), CL, Vss, Vz, MRT for TH-302 and its active metabolite Br-IPM (time frame: Days 1 and 8 of Cycle 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02076230.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2016.

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